Education and support tool for bladder cancer patients and caregivers
A Comprehensive Education and Navigational Support Program for Advanced Bladder Cancer
This study is testing a new support tool to help bladder cancer patients and their caregivers better manage their care and connect with resources.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Roswell Park Cancer Institute Academic / other |
| Locations | 1 site (Buffalo, New York) |
| Trial ID | NCT06414317 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates an education and navigation support tool (ENST) designed to enhance participation in care coordination for patients with locally advanced, metastatic, and unresectable bladder cancer and their caregivers. The study aims to assess organizational readiness, develop the ENST based on patient and caregiver needs, and implement the tool to improve care coordination. Participants will receive psychological distress and nutritional screenings, consultations, and access to virtual support groups throughout the study. The impact of the ENST will be measured using validated instruments to evaluate perceptions of care coordination and self-efficacy.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with metastatic or locally advanced, unresectable bladder cancer who are receiving or planning to receive systemic therapy.
Not a fit: Patients not receiving any form of systemic therapy for bladder cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the involvement of patients and caregivers in treatment decision-making and care planning for advanced bladder cancer.
How similar studies have performed: Other studies have shown success with similar educational and support interventions in improving patient engagement and care coordination.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * PATIENTS: Age ≥ 18 years * PATIENTS: Metastatic or locally advanced, unresectable bladder cancer * PATIENTS: Receiving or planning to receive systemic therapy for bladder cancer at Roswell Park Comprehensive Cancer Center (RPCCC) * PATIENTS: Subjects can be enrolled any time from initial diagnosis of advanced disease to within 8 weeks after initiation of first-line systemic therapy for advanced bladder cancer * PATIENTS: Able to speak, understand, read, and write English * CAREGIVERS: Age ≥ 18 years * CAREGIVERS: Only caregivers of enrolled patients will be included in the study * CAREGIVERS: Should be able to speak, understand, read, and write English * CAREGIVERS: Caregivers will be enrolled in the study during the same time window as for patient enrollment (from initial visit to within 8 weeks of patients starting frontline therapy) Exclusion Criteria: * PATIENTS: Not receiving any form of systemic therapy for bladder cancer due to Eastern Cooperative Oncology Group (ECOG) performance status (PS) \> 3, co-morbidities, or inadequate organ function * PATIENTS: Predominantly small cell histology * PATIENTS: Adults with impaired decision-making capacity, assessed by the study team to be unable to participate in ENST-based education and surveys * PATIENTS: Pregnant women * CAREGIVERS: Cognitively impaired adults/adults with impaired decision-making capacity * CAREGIVERS: Individuals who are not yet adults (infants, children, teenagers)
Where this trial is running
Buffalo, New York
- Roswell Park Cancer Institute — Buffalo, New York, United States (Recruiting)
Study contacts
- Principal investigator: Saby George, MD — Roswell Park Cancer Institute
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.